Over the past two decades, the promise of accelerated drug development and personalized medicine have brought heighten attention to the field of biomarker. But do you really know what biomarker are, how they are developed, and how they are used?
Here, I'll share over 15 years of experience in the fields of biomarker development and translational research to try to answer some of these questions.

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Tuesday, October 4, 2011

The Parkinson Progression Marker Initiative: An Emerging Success Story

In an
earlier post Biomarker
Qualification Consortia: The ADNI Success Story, I discussed the value of
biomarker qualification consortia by highlighting the success of the NIH
sponsored Alzheimer’s Disease Neuroimaging Initiative (ADNI).
Here, I would like to raise awareness to another biomarker qualification
consortium in the field of neurodegenerative medicine: the Michael J. Fox
Foundation sponsored Parkinson Progression Marker Initiative (PPMI).

PPMI
is a consortium of academic, industrial, and non-profit organizations dedicated
to the assessment and qualification of biomarkers of Parkinson’s disease (PD)
through the longitudinal monitoring of early PD patients. In contrast to ADNI, PPMI main sponsor is the
Michael J. Fox Foundation: a non-profit organization dedicated to the
advancement of PD treatment through scientific research and public awareness. PPMI has assembled a total of 21 sites in the
US and Europe which will recruit and follow 400 early PD patients and 200 age-matched
controls volunteers over a 5-year period.
Similarly to ADNI, PPMI has defined a set of standardized protocols for
the assessment of clinical (motor assessment, neuropsychiatric, olfaction) end
points and imaging (DATScan,
MRI, DTI),
biochemical (alpha-synuclein,
DJ-1, urate), and genetic
biomarkers. In keeping with the non-competitive
spirit of the consortium, all data collected by PPMI will be made available to
the scientific community through a centralized data repository. PPMI also intends to facilitate access the
biosamples collected from the study participants.

Although
PPMI has only been active since June 2010 and not all sites have been active
since the study start, the study has already enrolled 50% of the control
participants (goal: 200 individuals) and 31% of the PD participants (goal: 400
individuals).

As it
is common for studies of this magnitude, PPMI has encountered a few bumps in
the road. Although DATScan was approved by
the FDA for US use on January 14th 2011, this critical imaging
biomarker technology has not been available since February 2011 (status may
have changed since this information was released).